PreventionGenetics PGxome

Feb 14, 2017

PreventionGenetics launched the newly expanded PGxome whole-exome sequencing tests. In addition to diagnostic whole-exome testing, the PGxome Health Screen is now available to healthy individuals who want to learn more about their carrier status for recessive disorders and susceptibility to adult onset illnesses. Pharmacogenomic testing will be added to the PGxome test menu soon, PreventionGenetics said. 

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Aug 22, 2017

Sunquest Mitogen LIMS and Genetic Analysis Software

Sunquest Information Systems has released Sunquest Mitogen, a new laboratory information management system and genetic analysis software platform to support molecular diagnostics and precision medicine. Mitogen, based in part on technology Sunquest acquired when it bought GeneInsight and UniConnect in 2016, is meant to help both wet and dry labs move into next-generation sequencing. 

Aug 21, 2017

Natera Signatera

Natera has launched Signatera, a research-use-only circulating tumor DNA assay. Signatera consists of analyzing whole-exome sequencing data from a patient's tumor sample to design a targeted, custom-designed assay to analyze 16 or more mutations that were identified in the tumor sample. According to Natera, the assay can detect variant allele frequencies down to 0.01 percent and is optimized to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.

Aug 17, 2017

Exalenz Bioscience BreathID Hp Lab system

Exalenz Bioscience launched the BreathID Hp Lab system, an automated breath testing solution for detecting active carcinogenic H. pylori bacterial infection. The solution builds on the firm's BreathID Hp urea breath testing product, which has 99 percent sensitivity and specificity for detecting H. pylori, and delivers high lab throughput and management, while minimizing human error, and providing cost effectiveness. 

 

Aug 11, 2017

Cynvenio Biosystems PD-L1 Expression Assay

Cynvenio Biosystems has launched its second-generation PD-L1 expression test. The blood test has improved analytic performance compared to the first-generation test, enabling highly sensitive and specific profiling and monitoring of PD-L1 expression on lung cancer cells recovered from blood. Cynvenio is offering the test from its CLIA/CAP laboratory in California with a three- to seven-day turnaround time. The test is also available to all Cynvenio customers running its LiquidBiopsy platform and workflow, the company said.

Aug 11, 2017

SeraCare Zika Virus Reference Materials

SeraCare Life Sciences has launched a set of reference materials for vlaidaing and monitoring Zika virus test methods. The AccuSet Zika Performance Panel is a 10-member panel consisting of patient samples demonstrating a range of reactivity for Zika IGM antibodies, and assessed for cross-reactivity to dengue and chikungunya. The panel is intended for use by researchers, diagnostic manufacturers, and clinical laboratories to develop, evaluate, and validate Zika serological test methods. The panel members have been comprehensively tested following the recommended US Centers for Disease Control and Prevention algorithm and using several commercially available methods.

SeraCare also launched the AccuSpan Zika RNA Linearity Panel and the AccuPlex Zika RNA Reference Material, both formulated using the company's AccuPlex recombinant virus technology. These safe, non-replicative, non-infectious, and fully extractable positive reference materials support the development and evaluation of molecular diagnostics detecting Zika virus.

Aug 10, 2017

Color Familial Hypercholesterolemia Test

Color launched a genetic test for familial hypercholesterolemia, a hereditary condition that causes high cholesterol, and if untreated, can lead to coronary heart disease. One in 50 people with high cholesterol are born with FH, and are 22 times more likely to develop coronary heart disease than those without FH and normal cholesterol. The physician-ordered test, priced at $249, analyzes three genes known to commonly cause FH: APOB, LDLR, and PCSK9. If customers want to get the FH test with Color's hereditary cancer risk test, the price is $349.

Aug 10, 2017

Beckman Coulter Diagnostics Access 2

Beckman Coulter Diagnostics launched the Access 2 immunoassay system with enhanced features to improve ease of use, workflow efficiencies, system reliability, and customer satisfaction. An internal reagent barcode reader has been added to minimize operating loading errors. Other additions include an upgraded ergonomic workstation, improved fluidics tray, a status light bar, remote monitoring capability, and a "refreshed" look, the firm said.

Aug 09, 2017

Exosome Diagnostics MedOncAlyzer 170

Exosome Diagnostics launched the MedOncAlyzer 170, a liquid biopsy pan-cancer panel that interrogates exosomal RNA and circulating tumor DNA in one assay. MedOncalyzer 170 is a targeted panel for tumor profiling that identifies clinically actionable and functionally important mutations across multiple cancer types, using as little as 0.5 ml of patient blood or plasma. 

Aug 08, 2017

Meridian Bioscience ImmunoCard Stat Flu A&B

Meridian Bioscience today released its ImmunoCard Stat Flu A&B, an expansion of its ImmunoCard Stat product line. The product will detect the presence of influenza A & B in nasal and nasopharyngeal swabs, and can also be used to test nasal washes and aspirates. According to the company, the device will require a simple procedure with minimal interaction time that provides qualitative results in 10 to 15 minutes.

Aug 02, 2017

Asuragen Expanded QuantideX qPCR BCR-ABL Portfolio

Asuragen has launched a new CE-marked QuantideX qPCR BCR-ABL minor kit for identifying minor (e1a2) BCR-ABL fusion transcripts in patients with chronic myeloid leukemia. The new test joins the firm's existing FDA-cleared and CE-marked QuantideX qPCR BCR-ABL IS Kit that covers major (e13a2, e14a2) fusions.

The two kits can be combined in a streamlined and common workflow, and Asuragen said it is also expanding the capabilities of its QuantideX Reporter, analysis software, which accompanies the CE-marked QuantideX qPCR BCR-ABL IS Kit, to allow laboratories the ability to report CML patient disease burden on the International Scale after reviewing ABL1 copy number, in compliance with European LeukemiaNet guidelines.

Aug 02, 2017

Aalto Bio Reagents Recombinant Yellow Fever Virus Protein

Irish-based Aalto Bio Reagents announced its first-to-market recombinant Yellow Fever Virus (YFV) protein for diagnostic test manufacturers, vaccine developers, and researchers. The protein will satisfy an urgent need for a specific and sensitive serological VFV assay in tropical and subtropical countries in South America and Africa, where co-circulation with other flaviviruses is high, the company said. The polyhistidine-tag, recombinant protein is expressed in HEK293 cells and is derived from strain 17D. The mosquito-borne disease is normally difficult to diagnose, as cross-reaction with other flavivirus infections is common. Laboratory diagnosis is accomplished by means of serological testing for the detection of during the postviremic phase of VFV. There are no validated IgM ELISA kits commercially available at present, and in order for VFV infection to be confirmed by serological techniques, a differential diagnosis with other flavivirus infections must be carried out.

Jul 28, 2017

Roche Avenio Millisect System

Roche announced the commercial availability of the Avenio Millisect System, a tissue dissection instrument that utilizes an automated digitally assisted process to isolate clinically relevant cells from formalin-fixed paraffin-embedded tissue slides. The system is designed to address tissue dissection challenges in clinical labs where manual dissection lacks consistency and precision, and laser capture microscopy is cumbersome and costly, Roche said. Optimized to fit easily into a variety of clinical workflow configurations, the system allows precise and consistent recovery of regions of interest for molecular pathology, improving the results of diagnostic testing by reducing false negatives and allowing identification of additional potential therapeutic targets. The Avenio Millisect System is an IVD labeled medical device and is now available in the US and countries accepting the CE mark.

Jul 28, 2017

Agilent Technologies AriaDx Real-Time PCR System

Agilent Technologies has launched the AriaDx Real-Time PCR System in territories recognizing the CE mark for in vitro diagnostics. The modular design of customer-changeable optics in the instrument enables laboratories to use AriaDx with just one optical cartridge, and add more (up to six total) as required. The touchscreen and accompanying analysis software incorporates customer-favored features from the Stratagene Mx series while further increasing and streamlining analysis capabilities, Agilent said. The platform can be used for assays detecting gene expression, allele discrimination, and genotyping, and it is compatible with existing fast chemistry-based assays that are DNA-binding and probe-based. 

Jul 27, 2017

Beckman Coulter DxOne

Beckman Coulter Diagnostics launched the DxOne information management solution suite, which it called "an integrated system of technologies and capabilities, designed to ease data access and usability." DxOne leverages cloud computing, allow remote-access functionality.

Jul 24, 2017

Helix Genomics Marketplace

Personal genomics company Helix announced the opening of an online marketplace where customers can have their DNA sequence interpreted in a variety of contexts, including health, fitness, nutrition, recreation, family, and ancestry. The marketplace features mobile applications developed by partner companies: Admera, Azumio, DNAFit, DotOne, EverlyWell, Exploragen, Genome Medical, Insitome, Intelliseq, Lose It!, National Geographic, Sema4, Titanovo, and Vinome.

The initial exome sequencing through Helix is $80, in addition to the cost for each app. For example, Sema4's CarrierCheck app enabling screening for 67 conditions is available for $199. Instiome's app, for $29.99, allows customers to learn traits they may have inherited from Neanderthal ancestors, such as skin pigmentation, the ability to repair sun damage, learning capabilities, and torso shape. 

Additionally, customers can order an app from Admera for cardiac risk, inherited cholesterol and diabetes testing; learn about their genetic ancestry from National Geographic's app; learn about how their DNA might impact sleep patterns from Exploragen; order a variety of apps for weight management and fitness based on DNA information; and receive a DNA-based taste profile from Vinome. Nursing mothers can learn their levels of the Omega 3 fatty acid in breast milk via an app from EverlyWell. An app from DotOne will let individuals order a scarf with their own DNA information printed on it.

Before or after receiving any particular interpretation, customers can also get genetic counseling through Genome Medical's telemedicine network of genetic counselors.